Why it was recalled
Products failed the Antimicrobial Effectiveness Test
Product description
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)
Lot numbers, UPCs & expiration codes
Lot #: 7568 (Refer to 13F0007), Exp 04/15; 7569 (Refer to 13F0008), Exp 05/15; 7618 (Refer to 13G0013), 7619 (Refer to 13F0013), Exp 07/15; 7620 (Refer to 13I0001), Exp 08/15 NDC 0363-0050-01.
Where it was sold
Nationwide to 13 Walgreen Distribution Centers and Pharmacies.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-967-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 16, 2015
- FDA report date
- Apr 29, 2015
- Quantity
- 104,810 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tarmac Products, Inc.
Original FDA data
Every field from FDA enforcement report D-967-2015, exactly as published.
Show all FDA fields
- City
- Miami Gardens
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 71031
- Address
- 16311 NW 52nd Ave
- Code information
- Lot #: 7568 (Refer to 13F0007), Exp 04/15; 7569 (Refer to 13F0008), Exp 05/15; 7618 (Refer to 13G0013), 7619 (Refer to 13F0013), Exp 07/15; 7620 (Refer to 13I0001), Exp 08/15 NDC 0363-0050-01.
- Postal code
- 33014-6209
- Report date
- Apr 29, 2015
- Product type
- Drugs
- Recall number
- D-967-2015
- Classification
- Class II
- Recalling firm
- Tarmac Products, Inc.
- Product quantity
- 104,810 bottles
- Termination date
- Mar 3, 2017
- Reason for recall
- Products failed the Antimicrobial Effectiveness Test
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)
- Distribution pattern
- Nationwide to 13 Walgreen Distribution Centers and Pharmacies.
- Recall initiation date
- Apr 16, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 22, 2015